Core Stabalization and Rebound Therapy and CP

Sponsor

Cairo University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05739396

Collaborator

(none)

Enrollment

Location

Arms

5.3

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the study aims to compare the effect of core stabalization and rebound therapy on balance in children with hemiplegic cerebral palsy

Condition or Disease	Intervention/Treatment	Phase
Whole Body Vibration Rebound Therapy Balance cp	Other: core stabilization	N/A

Detailed Description

PURPOSE:

To compare the effect of core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy

BACKGROUND:

Cerebral palsy is primarily a disorder of movement and posture

HYPOTHESES:

There is no significant difference between core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy.

RESEARCH QUESTION:

Is there a significant difference between core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy?

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Core Stabalization Versus Rebound Therapy on Balance in Children With Cerebral Palsy

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: core stabalization The core stability exercises will be used for core stabilization training of group (A) in addition to traditional physical therapy. The core stability program included 3 levels. Each exercise lasted 5 min, and the children shifted from one exercise to the next after the complete performance of the preceding exercise. The first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10-20 repetitions), and supine twist (10-20 repetitions). The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3-5 s, followed by a slow relaxation phase, with 10-20 repetitions)	Other: core stabilization The treatment session lasted one hour with short breaks of around 10 minutes and will be conducted three times per week for twelve successive weeks Other Names: rebound therapy
Experimental: rebound therapy Rebound exercises will be applied for group B. this group will receive rebound exercise training in addition to traditional physical therapy . Rebound exercises were conducted on a mini-trampoline and BOSU ball. Passive bouncing will be conducted while the child was standing with his/her feet a shoulder-width apart. The therapist will held the child's legs while applying upward and downward movement. The bouncing started slowly. The child then will progress to include the rebound exercises, starting with active bounce, where in a hands free manner the therapist will ask the child to speed up or slow down the bounce rate according to the child's abilities	Other: core stabilization The treatment session lasted one hour with short breaks of around 10 minutes and will be conducted three times per week for twelve successive weeks Other Names: rebound therapy

Arm

Intervention/Treatment

Experimental: core stabalization

The core stability exercises will be used for core stabilization training of group (A) in addition to traditional physical therapy. The core stability program included 3 levels. Each exercise lasted 5 min, and the children shifted from one exercise to the next after the complete performance of the preceding exercise. The first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10-20 repetitions), and supine twist (10-20 repetitions). The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3-5 s, followed by a slow relaxation phase, with 10-20 repetitions)

Other: core stabilization

The treatment session lasted one hour with short breaks of around 10 minutes and will be conducted three times per week for twelve successive weeks

Other Names:

rebound therapy

Experimental: rebound therapy

Rebound exercises will be applied for group B. this group will receive rebound exercise training in addition to traditional physical therapy . Rebound exercises were conducted on a mini-trampoline and BOSU ball. Passive bouncing will be conducted while the child was standing with his/her feet a shoulder-width apart. The therapist will held the child's legs while applying upward and downward movement. The bouncing started slowly. The child then will progress to include the rebound exercises, starting with active bounce, where in a hands free manner the therapist will ask the child to speed up or slow down the bounce rate according to the child's abilities

Other: core stabilization

The treatment session lasted one hour with short breaks of around 10 minutes and will be conducted three times per week for twelve successive weeks

Other Names:

rebound therapy

Outcome Measures

Primary Outcome Measures

balance [12 week]
it measures the degree of tilting for each axis during dynamic conditions and calculates a medial lateral stability index (MLSI); an anterior-posteriorstability index (APSI); and an overall stability index(OSI),

Secondary Outcome Measures

gross motor function measure-88 [12 week]
measure gross motor function. higher scores indicate better outcome. scores are reported in percentage.
lafayette hand held dynamometer [12 week]
measure isometric muscle strength of knee flexors and extensors. higher scores reflect better outcome
6 minute walk test [12 week]
measure endurance.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

children diagnosed with spastic hemiplegic CP.
Their chronological age ranged from 5 to 8 years,
able to follow verbal commands or instructions during testing procedures,
degree of spasticity in affected lower limbs ranged between1 to 1+ according to Modified Ashworth scale (MAS),
they are able to understand and follow instructions given to them,

Exclusion Criteria:

Children who had significant visual or auditory problems that may interfere with testing, - ---- patients who had contractures or fixed deformities related to the joints of the lower limbs, ---- injection with Botulinium toxin or any orthopaedic surgery in lower limbs 6m before study,
children who were suffering from cardiopulmonary problems or epilepsy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty Of Physical Therapy	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Faculty OP Therapy, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alaa Fahmy Hassan Al Nemr, lecturer in pediatric department, faculty of physical therapy, Cairo University

ClinicalTrials.gov Identifier:

NCT05739396

Other Study ID Numbers:

P.T.REC/012/003117

First Posted:

Feb 22, 2023

Last Update Posted:

Mar 1, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 1, 2023